Medical Device

Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables A

Recall date: 2026-10-28 · Source: FDA_DEVICE

Brand / Firm

Product

Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister packaged.

Reason for recall

The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.

Units affected

230856

Description

View official recall notice →